Safety Information: Stryker Wingspan Stent System

After reviewing updated safety and risk information, FDA changed the indications for use and labeling for Stryker’s Wingspan Stent System (“Wingspan”) by limiting approval to a very specific group of patients who are at serious risk of lifte-threatening stroke and have limited alternative treatment options.   The Wingspan should not be used for:

•  the treatment of stroke with an onset of symptoms within seven days or less, or
•  for treatment or for the treatment of transient ischemic attacks (TIAs).  
  

Wingspan is used to open narrowed arteries in the brains of patients diagnosed with intracranial stenosis who are experiencing repeated strokes. Stenosis, or narrowing of the intracranial arteries, is a serious condition caused by a buildup of plaque within the arteries, and there are few treatment options available for managing this condition. Patients with intracranial stenosis are at serious risk of life-threatening strokes due to reduced blood flow to the brain from narrowed or blocked arteries. The Wingspan stent is intended to reopen narrowed arteries in certain patients to potentially prevent additional strokes. 
[1] FDA Safety Communication, "Narrowed Indications for Use for the Stryker Wingspan Stent System" (January 31, 2013).